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Solutions for End to End Bioprocessing with Integrated Automation
Solutions for End to End Bioprocessing with Integrated Automation
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At Sartorius Stedim Biotech Integrated Solutions we provide a unique imple-mentation methodology for your bioprocess using single-use technologies wherever possible and hybrid solutions as appropriate for your type & scale of process. Our teams develop the layout, workflow and design of your bioprocess equipment based upon your process needs.
Parallel to your process design, we also consider the need and importance of state of the art automation systems to maximize process efficiency and minimize risk. At Integrated Solutions, we engineer, design, and implement flexible automation platforms and management information systems to match your industrial needs.
By working in close corporation with Siemens, we are able to provide core competencies in both bioprocess and automation engineering. This is the key to success for your next Biomanufacturing facility.
Customer Single Use Process
Siemens Core Competences
Sartorius Core Competences
Sartorius and Siemens: Partners for your Success
l Intuitive Systems Tailored to your Process
l Possibilities for Process Optimization through Flexible Configurations
l Faster Time to Market
l Decreased Engineering Effort through Quality of Design
l Expedited Project Execution
l Accelerated and Reliable Start of Production
l Lower Initial Investment
l Precise Cost Determination and Allocation in Early Design Phases of production
Maximize Your Process Efficiency
The Sartorius New Automation Platform combines hardware, software and consumables in a unique way to ensure full functionality, best-in-class supply chain, serviceability and hence enables single-use commercial manufacturing.
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Integrated Solutions is designing and implementing process solutions for the biopharmaceutical industry under consideration of time-to-market, quality and cost targets. Process Automation is a key element to reach these targets. The collaboration between Sartorius and Siemens supports our customers to manage the challenges of the future. Dr. Thorsten Peuker, Vice President Integrated Solutions, Sartorius Stedim Biotech
“
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The Sartorius Integrated Solutions approach “Process4Success®” describes the engineering philosophy for entire single-use processes. Well defined sequences of pre-defined unit operations are combined to the entire process lines. These platform processes will support present and future progress in biopharmaceutical development and production in order to shorten the time-to-market by minimising engineering efforts and installation work.
Process4Success® guarantees
h High Quality
h High Investment reliability
h Short Leadtime
USPMP/BP DSP
Process4Success®
Fill & Finish
Customer Single Use Process
Process4Success® – The Sartorius Process Platform
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With Process4Success® (P4S), Sartorius does not only offer the platform, but furthermore a customised solution which meets individual customer requirements. The customers can concentrate on their core competences, and Sartorius offers the process know-how and relieves the customer. From the definition of the process up to the integration into customer IT infrastructures, Sartorius provides the solution – the “all-around carefree package”. Process4Success® shortens the realization time supporting faster time to market.
Development lifecycle model
To ensure our projects meet customer and cGMP requirements, a rigorous development lifecycle model is followed: starting from day one through to all engineering design, manufacturing and qualification test phases.
For more information on our Integrated Solutions Platforms, please visit:www.sartorius.com/en/integrated-solutions
User Requirement Specification
Process Qualification
Functional Specification
Operational Qualification
Design Specification
Installation Qualification
Assembling of Process Equipment
Responsibility of Customer
Responsibility of Sartorius
time
Project Qualification
- Full level of IQ | OQ procedures – Fully documented in test reports
- In accordance with cGMP requirements
Project Definition
- Decomposition of customer process requirements
- Creation of system specifications
Datum / Date Name
BearbeiterDrawn
GeprüftChecked
Ind. Änderung /Revision Dat ./Date Name Ursprung /Origin
Document -Nr./Document -no. Format /Size
A0
Artikel -Nr./Article -no. Blatt/Sheet
1/1Ers . f./Repl . for Ers . d./Repl . by
Für diese Zeichnung behalten wir uns alle Rechte vor / This drawing is the property of Sartorius Stedim Biotech
Stat . -
Customer /Kunde
Profibus
Control Network
Discrete I /O
Server PC
Operator Station
Switch
DCUController
Instrument
Balance
SolenoidValves
PLC -CPU
RemoteI/O
Dong -A NetworkVFD
Laptop
Touch Panel 19"
WinCC
OS
hPrinter
CELL CULTURE - BRX
10 AI02 AO08 DI40 DO
CPU :317 -22,0 MB + 8MB
Picd 1
12 AI08 AO08 DI08 DO04 EM16 Ph00 Op
BR 2060500 L Seed Bioreactor
Managed Switch
BR 2050200 L Seed Bioreactor
CH 1080Depth Filtration
CPU :317 -22,0 MB + 8MB
12 AI08 AO08 DI08 DO04 EM16 Ph00 Op
CPU :317 -22,0 MB + 8MB
Picd 1
12 AI08 AO08 DI08 DO04 EM16 Ph00 Op
BR 20702000 L Production
Bioreactor
CPU :317 -22,0 MB + 8MB
HARVEST
BR 204020L Seed Bioreactor
CPU :317 -22,0 MB + 8MB
12 AI08 AO08 DI08 DO04 EM16 Ph00 Op
DCS Operator Station
Picd 1
12 AI08 AO08 DI08 DO04 EM16 Ph00 Op
BR 50702000 L Production
Bioreactor
CPU :317 -22,0 MB + 8MB
DCS Operator Station
Managed Switch
Picd 1
12 AI08 AO08 DI08 DO04 EM16 Ph00 Op
BR 1060500 L Seed Bioreactor
BR 1050200 L Seed Bioreactor
CPU :317 -22,0 MB + 8MB
12 AI08 AO08 DI08 DO04 EM16 Ph00 Op
CPU :317 -22,0 MB + 8MB
Picd 1
12 AI08 AO08 DI08 DO04 EM16 Ph00 Op
BR 10702000 L Production
Bioreactor
CPU :317 -22,0 MB + 8MB
BR 104020L Seed Bioreactor
CPU :317 -22,0 MB + 8MB
12 AI08 AO08 DI08 DO04 EM16 Ph00 Op
DCS Operator Station
Picd 1
12 AI08 AO08 DI08 DO04 EM16 Ph00 Op
BR 40702000 L Production
Bioreactor
CPU :317 -22,0 MB + 8MB
Managed Switch
CELL CULTURE - MEDIA
Managed Switch
CPU :317 -21,0 MB + 8MB
08 AI04 AO08 DI08 DO
MP 9020400 L Media Mixing
System
MP 901020L Media Mixing
System
OPC
DCS Operator Station
CPU :317 -21,0 MB + 8MB
MP 9030400 L Media Mixing
System
08 AI04 AO08 DI08 DO
CPU :317 -21,0 MB + 8MB
MP 90401500 L Media Mixing
System
08 AI04 AO08 DI08 DO
Managed Switch
08 AI04 AO08 DI08 DO
CPU :317 -21,0 MB + 8MB
UD 1160UF /DF Skid
FO 1170Formulations
Skid
DCS Operator Station
08 AI04 AO08 DI08 DO
CPU :317 -21,0 MB + 8MB
CR 1130CEX Chromo
Skid
CR 1090Protein A Chromo
Skid
VR 1150 Virus Filtration
Skid
CR 1140AEX Chromo
SkidVI 1100Virus Inactivation
Skid
OPC
OPC
08 AI04 AO08 DI08 DO
CPU :317 -21,0 MB + 8MB
08 AI04 AO08 DI08 DO
CPU :317 -21,0 MB + 8MB
Picd 1
CPU :317 -21,0 MB + 8MB
08 AI04 AO08 DI08 DO
DCS Operator Station
PURIFICATION – PRE VIRAL PURIFICATION – POST VIRAL
Managed Switch
CH 1080Clarified Harvest
OS Server redundantEngineering Station
Managed Switch
Printer
Historian
Batch RecipesPCS 7 CL 7 PCS 7 CL 8 PCS 7 CL 9
Managed Switch
PCS 7 AS 410
UPS /DST2000 l
SERVER ROOM / CONTROL ROOM
SimApi
Simca -Client
Simca -Online Server
Batch Server redundant
VIRTUAL MACHINE SERVER DATA ANALYTICS
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Besides equipment, automation and integration into an MES infrastructure are fundamental to a successful project execution. The goal is flexibility in automation.
Sartorius single-use equipment can easily be integrated into a distributed control system (DCS). This open system architecture covering the entire production process ensures an efficient interaction of all automation components. This is supported by consistent data management, global standard compliancy and uniform software interfaces.
Our preferred automation solution is based on Siemens technologies. Siemens ensures continuity and reliability regarding availability and support throughout the complete life cycle of the plant.
In addition to the openness of an integrated system architecture, this holistic automation approach paves the way for intelligent bioprocessing by means of Multivariate Data Analytics (MVDA) and real-time data acquisition and monitoring of your bioprocesses. Siemens SIMATIC PCS 7 works together with MVDA software packages provided by Sartorius Stedim Data Analytics (formerly Umetrics) , a world leader in MVDA technology.
Automation: The Backbone for Successful Project Execution and Smart Bioprocessing
DCS System Architecture for a fully integrated SU Process Line
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Leading provider for end-to-end bioprocess solutions from concept to realization.
Siemens Core Competence
Sartorius Core Competence
Leading provider of industrial automation solutions.
l Decreased Risk
l Increased Quality
l Flexibility
l Security of Investment
l Faster Time to Market
l Maximum Productivity
Customer Benefits
The use of industrial standards in automation guarantees stable systems with minimized risk and faster time to production within the predicted cost frame.
The implementation of a Distributed Control System (DCS), like Siemens SIMATIC PCS 7, fulfills today‘s requirements of biopharmaceutical industries, like plant-wide recipe control, full electronical batch reporting (eBR), review by exception (RBE) and plant-wide visualization.
The advantages of the Sartorius – Siemens automation approach includes a seamless scalable solution, from fulfillment of basic GMP requirements via batch management up to paperless manufacturing. Sartorius package units (PU) can be easily drag-and-dropped into Simatic PCS 7, creating an integrated bioprocess line. This not only decreases engineering effort and implementation time, but also provides the flexibility to change and add PU’s on demand. Additionally, there is no risk to open an engineering change management process (ECM) for pre-qualified PU’s.
Both Sartorius and Siemens share a proven track record and provide full level local support and remote maintenance access as well as personalized service packages and maintenance contracts.
Sartorius and Siemens:Partners for your Success
The partnership between Sartorius and Siemens guarantees a highly qualitive and proven automation solution incl. MES based on gobal standards. Our deep familiarity with the Sartorius products allows us to develop dedicated standards for automation. This proven concept assures fast track project execution and thus early start of production. Hannspeter Pachel, Senior Consultant Account Development, Siemens AG
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Sales and Service ContactsFor further contacts, visit www.sartorius-stedim.com
EuropeGermanySartorius Stedim Biotech GmbHAugust-Spindler-Strasse 1137079 Goettingen
Phone +49.551.308.0Fax +49.551.308.3289
Sartorius Stedim Systems GmbHRobert-Bosch-Strasse 5 – 7 34302 Guxhagen
Phone +49.5665.407.0Fax +49.5665.407.2200
FranceSartorius Stedim FMT S.A.S.ZI des PaludsAvenue de Jouques – CS 9105113781 Aubagne Cedex
Phone +33.442.845600Fax +33.442.845619
Sartorius Stedim France SASZI des PaludsAvenue de Jouques – CS 7105813781 Aubagne Cedex
Phone +33.442.845600Fax +33.442.846545
AustriaSartorius Stedim Austria GmbHModecenterstrasse 221030 Vienna
Phone +43.1.7965763.18Fax +43.1.796576344
BelgiumSartorius Stedim Belgium N.V.Rue Colonel Bourg 1051030 Bruxelles
Phone +32.2.756.06.80Fax +32.2.756.06.81
HungarySartorius Stedim Hungária Kft.Kagyló u. 52092 Budakeszi
Phone +36.23.457.227Fax +36.23.457.147
ItalySartorius Stedim Italy S.r.l.Via dell’Antella, 76/A50012 Antella-Bagno a Ripoli (FI)
Phone +39.055.63.40.41Fax +39.055.63.40.526
NetherlandsSartorius Stedim Netherlands B.V.
Phone +31.30.60.25.080Fax +31.30.60.25.099
PolandSartorius Stedim Poland Sp. z o.o.ul. Wrzesinska 7062-025 Kostrzyn
Phone +48.61.647.38.40Fax +48.61.879.25.04
Russian FederationLLC “Sartorius Stedim RUS”Vasilyevsky Island5th line 70, Lit. A199178 St. Petersburg
Phone +7.812.327.53.27Fax +7.812.327.53.23
SpainSartorius Stedim Spain, S.A.U.Avda. de la Industria, 32Edificio PAYMA28108 Alcobendas (Madrid)
Phone +34.913.586.098Fax +34.913.589.623
SwitzerlandSartorius Stedim Switzerland AGRingstrasse 24 a8317 Tagelswangen
Phone +41.52.354.36.36Fax +41.52.354.36.46
U.K.Sartorius Stedim UK Ltd.Longmead Business CentreBlenheim Road, EpsomSurrey KT19 9 QQ
Phone +44.1372.737159Fax +44.1372.726171
UkraineLLC “Sartorius Stedim RUS”Post Box 440 “B”01001 Kiev, Ukraine
Phone +380.44.411.4918Fax +380.50.623.3162
AmericasUSASartorius Stedim North America Inc.5 Orville Drive, Suite 200Bohemia, NY 11716
Toll-Free +1.800.368.7178Fax +1.631.254.4253
ArgentinaSartorius Argentina S.A. Int. A. Ávalos 4251 B1605ECS Munro Buenos Aires
Phone +54.11.4721.0505 Fax +54.11.4762.2333
BrazilSartorius do Brasil Ltda Avenida Senador Vergueiro 2962 São Bernardo do Campo CEP 09600-000 - SP- Brasil
Phone +55.11.4362.8900Fax +55.11.4362.8901
MexicoSartorius de México, S.A. de C.V.Libramiento Norte de Tepotzotlan s/n,Colonia Barrio Tlacateco,Municipio de Tepotzotlan,Estado de México,C.P. 54605
Phone +52.55.5562.1102Fax +52.55.5562.2942
PeruSartorius Peru S.A.C.Avenue Alberto del Campo 411 Floor 12 – The Office15076 – San Isidro, Lima
Phone +51.1.441 0158 Fax +51.1.422 6100
Asia|PacificAustraliaSartorius Stedim Australia Pty. Ltd.Unit 5, 7-11 Rodeo DriveDandenong South Vic 3175
Phone +61.3.8762.1800Fax +61.3.8762.1828
ChinaSartorius Stedim Biotech (Beijing) Co. Ltd.No. 33 Yu’an RoadAirport Industrial Park Zone BShunyi District, Beijing 101300
Phone +86.10.80426516Fax +86.10.80426580
Sartorius Stedim (Shanghai) Trading Co., Ltd.3rd Floor, North Wing, Tower 1No. 4560 Jinke RoadZhangjiang Hi-Tech Park Pudong DistrictShanghai 201210, P.R. China
Phone +86.21.6878.2300Fax +86.21.6878.2882
Sartorius Stedim Biotech (Beijing) Co. Ltd.Guangzhou Representative OfficeUnit K, Building 23Huihua Commerce & Trade BuildingNo. 80 Xianlie Middle RoadGuangzhou 510070
Phone +86.20.37618687 | 37618651Fax +86.20.37619051
IndiaSartorius Stedim India Pvt. Ltd.#69/2-69/3, NH 48, JakkasandraNelamangala Tq562 123 Bangalore, India
Phone +91.80.4350.5250Fax +91.80.4350.5253
JapanSartorius Stedim Japan K.K.4th Fl., Daiwa Shinagawa North Bldg.8-11, Kita-Shinagawa 1-chomeShinagawa-ku, Tokyo, 140-0001 Japan
Phone +81.3.4331.4300Fax +81.3.4331.4301
MalaysiaSartorius Stedim Malaysia Sdn. Bhd.Lot L3-E-3B, Enterprise 4Technology Park MalaysiaBukit Jalil57000 Kuala Lumpur, Malaysia
Phone +60.3.8996.0622Fax +60.3.8996.0755
SingaporeSartorius Stedim Singapore Pte. Ltd.10 Science Park Rd The Alpha #02-13/14Singapore Science Park IISingapore 117684
Phone +65.6872.3966Fax +65.6778.2494
South KoreaSartorius Korea Biotech Co., Ltd.8th Floor, Solid Space B/D, PanGyoYeok-Ro 220, BunDang-GuSeongNam-Si, GyeongGi-Do, 463-400
Phone +82.31.622.5700Fax +82.31.622.5799
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www.sartorius.com/en/integrated-solutions
For more information on our Integrated Solutions Platforms, please visit:www.sartorius.com/en/integrated-solutions
Solutions for End to End Bioprocessingwith Integrated AutomationMaximize Your Process EfficiencyProcess4Success® –The Sartorius Process PlatformAutomation: The Backbone for SuccessfulProject Execution and Smart BioprocessingSartorius and Siemens:Partners for your SuccessSales and Service Contacts
